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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
DeviceRIANEN I125
Classification Namekit, assay, estrogen receptor
Generic Namekit, assay, estrogen receptor
Regulation Number864.1860
4417 lancaster pike
wilmington, DE 19805
PMA NumberP800061
Supplement NumberS001
Date Received10/22/1980
Decision Date06/02/1981
Product Code
Advisory Committee Clinical Chemistry
Expedited Review Granted? No
Combination Product No